Thorens 10,000units/ml oral drops

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Colecalciferol

Available from:

Galen Ltd

ATC code:

A11CC05

INN (International Name):

Colecalciferol

Dosage:

10000unit/1ml

Pharmaceutical form:

Oral drops

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 09060400; GTIN: 5016298407310

Patient Information leaflet

1
PATIENT INFORMATION LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
THORENS 10 000 I.U. /ML ORAL DROPS, SOLUTION
CHOLECALCIFEROL (VITAMIN D
3
)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE, BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU
.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, or pharmacist, or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may
harm them, even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, or pharmacist, or
nurse. This includes
any possible side effects not listed in this leaflet. See section 4
WHAT IS IN THIS LEAFLET
1.
What THORENS is and what it is used for
2.
What you need to know before you use THORENS
3.
How to use THORENS
4.
Possible side effects
5.
How to store THORENS
6.
Contents of the pack and other information
1.
WHAT THORENS IS AND WHAT IT IS USED FOR
THORENS oral drops contains cholecalciferol (vitamin D
3
). Vitamin D
3
, can be found in
some foods and is also produced by the body when skin is exposed to
sunlight. Vitamin D
3
helps
the
kidneys
and intestine
absorb
calcium
and
it helps
build
bones. Vitamin
D
3
deficiency is the predominant cause of rickets (defective
mineralization of bones in children)
and osteomalacia (inadequate mineralization of bones in adults).
THORENS oral drops are used:
•
to prevent rickets in children (defective mineralization of bones
predominantly due to
vitamin D
3
deficiency) and osteomalacia in adults (inadequate mineralization of
bones
predominantly due to vitamin D
3
deficiency).
•
to prevent rickets in preterm newborns.
•
to prevent vitamin D
3
deficiency in children and adults when a risk of deficiency is
identified.
•
to prevent vitamin D
3
deficiency in children and adults with problems in absorbing
food (malabsorption) defined by doctor.
•
to treat rickets in children and osteomalacia in adults.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE THOR

Summary of Product characteristics

OBJECT 1
THORENS 10 000 I.U. /ML ORAL DROPS, SOLUTION
Summary of Product Characteristics Updated 02-Sep-2015 | Galen Limited
1. Name of the medicinal product
THORENS 10 000 I.U. /ml oral drops, solution
2. Qualitative and quantitative composition
1 ml oral solution (50 drops) contains 10 000 I.U. cholecalciferol
(vitamin D
3
), equivalent to 0.25 mg.
1 drop contains 200 I.U. cholecalciferol (vitamin D
3
)
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Oral drops, solution.
Clear and colorless to greenish-yellow oily solution without visible
solid particles and/or precipitate
4. Clinical particulars
4.1 Therapeutic indications
• Prophylaxis of rickets and osteomalacia in children and adults
• Prophylaxis of rickets in preterm newborns
• Prophylaxis of vitamin D deficiency in children and adults with an
identified risk
• Prophylaxis of vitamin D deficiency in children and adults with
malabsorption
• Treatment of rickets and osteomalacia in children and adults
4.2 Posology and method of administration
1 drop contains 200 IU vitamin D
3
.
• Paediatric posology
- prevention of deficiency 0-1 years 400 IU/day (2 drops)
- prevention of deficiency 1-18 years 600 IU/day (3 drops)
- doses of up to 1000 IU/day (5 drops) may be required to prevent
deficiency in some children
- treatment of deficiency 0-18 years 2000 IU/day (10 drops) for 6
weeks, followed by maintenance
therapy of 400-1000 IU/day (2 – 5 drops).
• Pregnancy and breast-feeding posology
- prevention of deficiency 400 IU/day (2 drops)
- doses of up to 2000 IU/day (10 drops) may be required to prevent
deficiency in some women (see
below)
- even higher doses may be required during breast-feeding if women
choose not to give the infant a
vitamin D
3
supplement
• Adult posology
- prevention of vitamin D
3
deficiency 600 – 800 IU/day (3 – 4 drops). Higher doses may be
required in
certain situations, see below.
- as an adjunct to specific therapy for osteoporosis: 800 IU/day (4
drops)
• Certain populations are at high risk